A product's safety and quality depend to a great extent on its conformance to specifications that have been tested and proven safe. For this reason, a nonconformance system that is adequate is critical for the proper handling of nonconforming products. This is discussed in FDA regulations covering drugs, medical devices, and biologics; it is also discussed in ISO international standards, which apply to manufacturers of a wide range of consumer goods.

Nonconformance Software Systems for Product Materials and Finished Goods

Most general manufacturers and their suppliers comply with ISO international standards to help maintain the highest quality standards and compete better in the global market. ISO 9001:2000 and ISO 14001:2004, both widely used in this industry, require the establishment and maintenance of procedures for manufacturing nonconformance to ensure product safety. Adherence to ISO standards is voluntary, although certain countries require ISO certification and many customers prefer vendors and suppliers that are ISO-certified. MasterControl provides nonconformance software systems to ensure compliance of product materials and finished goods according to ISO regulations.

Nonconformance Systems for ISO 14000 and EPA Compliance

Oil and gas companies find it beneficial to conform to ISO quality standards, such as ISO 9000 and ISO 14000, to help ensure safe, reliable, and high-quality products and services. Adherence to ISO standards is largely voluntary, but the U.S. Environmental Protection Agency (EPA) encourages the use of ISO 14000 to help organizations improve their environmental performance and to prevent pollution. Both ISO 9001:2000 and ISO 14001:2004 require the establishment and maintenance of nonconformance systems to attain the highest quality standards.

Let’s see how the nonconformance software systems from MasterControl and MasterControl CAPA can help ensure that your quality initiatives are always Compliant, Connected, and Complete:

Sustained Compliance: The nonconformance software systems from MasterControl is designed not only to help meet ISO standards and attain FDA compliance, but to sustain compliance over the long term by optimizing the nonconformance disposition process, speeding up turnaround from initiation to approval, and keeping the overall quality system always ready for inspections and audits.

• Increased Efficiency Through Automation: MasterControl automates all tasks pertaining to handling of a nonconformance, including notification, follow-up, and escalation of overdue assignments. Automation helps simplify the compliance environment, making it easier to stay compliant.
• Centralized Repository: All documents related to nonconformance will be stored in a secure, centralized repository within the nonconformance software, making it easy to search and retrieve them during audits.
• Best-Practice Form: A pre-configured, multi-page form simplifies the process for nonconformance and accelerates evaluation and disposition of nonconforming materials by prompting the appropriate departments to collect and track all relevant data. The form is automatically routed through the nonconformance software to responsible personnel and escalates accordingly if the case is not processed promptly.
• Best-Practice Process: This solution incorporates a five-step process that will help the quality unit make timely and appropriate decisions. The process will guide the team from initiation through investigation, recommendation, disposition, and management approval.
• Analytics Reporting Tool: The nonconformance systems include a standard set of pre-configured reports that can be customized by end users. Nonconformances can be trended, and incidents analyzed by material, shift, machine, supplier, etc. These "data-mining" capabilities can give important insight into systemic quality issues and serve as another starting point for CAPA.
• Revision Control: MasterControl provides automatic revision control to ensure that only the current version of a document is available. When a user makes a change in the InfoCard (the MasterControl tool that provides basic information for every record), the user must enter a reason for the change. The nonconformance software tracks all changes made to the InfoCard.

Connected Nonconformance Systems

Integrated Quality Management: MasterControl connects the nonconformance disposition process with other quality processes for a holistic approach to quality management.

• Easy Access: MasterControl is Web-based so it can connect employees, suppliers, and others involved in the nonconformance system regardless of location.
• Flexible Process: The nonconformance software from MasterControl can be used as a stand-alone process for the purpose of small-scale, localized disposition of nonconforming materials. But the system is flexible and it allows integration with the CAPA process if the situation warrants a separate CAPA handling while the initial nonconformance is independently processed and closed.
• Form-to-Form Launching: A CAPA form can be launched directly from a nonconformance form, connecting one process to the next. Not only does MasterControl streamline this process, but it also maintains the links so one can review a completed process and easily see what triggered the CAPA. Relevant information from the nonconformance form will be automatically entered into the CAPA form, reducing data entry and increasing accuracy.

Complete Nonconformance Software

Enterprise-wide Product Application: MasterControl can handle every department's forms-based processes, making it an ideal enterprise-wide solution.

• Integrates with Other Applications: MasterControl's nonconformance software can integrate with other applications like ERP, LIMS, accounting, and human resources applications to accommodate departmental needs.
• Easy to Search: A standardized Google-like search window comes with the nonconformance software and with all integrated applications from MasterControl, which means all authorized users throughout the organization can search and retrieve change control-related tasks and documents.
• Easy to Find: MasterControl's Explorer, similar to Windows Explorer, is an easy-to-use tool that helps users find and access documents quickly. Every department can maintain its own Explorers and documents can be stored in multiple Explorers. System administrators can control and automatically update the documents through a dynamic link in the InfoCard.
• Automation of Forms-Based Processes: Any forms-based process unique to a department (i.e., application forms for HR, customer satisfaction survey forms for Customer Service Department) can be automated. A department can keep the look and function of existing forms or create entirely new ones within the nonconformance software.

For More Information on Nonconformance Software Systems

For more information about nonconformance software and nonconformance systems please feel free to contact a MasterControl representative.